cladribine

Generic: cladribine

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cladribine
Generic Name cladribine
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

cladribine 1 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-140
Product ID 63323-140_77a36c8d-5dde-47a1-a50c-77239395cee2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076571
Listing Expiration 2026-12-31
Marketing Start 2004-12-01

Pharmacologic Class

Established (EPC)
purine antimetabolite [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323140
Hyphenated Format 63323-140

Supplemental Identifiers

RxCUI
240754
UPC
0363323140106
UNII
47M74X9YT5
NUI
N0000175712

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cladribine (source: ndc)
Generic Name cladribine (source: ndc)
Application Number ANDA076571 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-140-10) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

63323-140-10 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-140-10) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

cladribine (1 mg/mL)

Linked Drug Pages (1)

Cladribine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "77a36c8d-5dde-47a1-a50c-77239395cee2", "openfda": {"nui": ["N0000175712"], "upc": ["0363323140106"], "unii": ["47M74X9YT5"], "rxcui": ["240754"], "spl_set_id": ["a2592a9b-bca6-4a5a-89c2-855a0634d5fe"], "pharm_class_epc": ["Purine Antimetabolite [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (63323-140-10)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "63323-140-10", "marketing_start_date": "20041201"}], "brand_name": "Cladribine", "product_id": "63323-140_77a36c8d-5dde-47a1-a50c-77239395cee2", "dosage_form": "INJECTION", "pharm_class": ["Purine Antimetabolite [EPC]"], "product_ndc": "63323-140", "generic_name": "CLADRIBINE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cladribine", "active_ingredients": [{"name": "CLADRIBINE", "strength": "1 mg/mL"}], "application_number": "ANDA076571", "marketing_category": "ANDA", "marketing_start_date": "20041201", "listing_expiration_date": "20261231"}